Dienstag, 28. März 2017

This marcus evans forum will discuss key challenges in biologics development, confronting formulation scientists and assist them with a better experiment protocol to ensure quality processes, efficient methodology and minimise failure risks. The delegates will benefit from experienced case study and understand how to improve formulation stability, preventing aggregation, develop high-concentration forms; they will also learn how to use predictive and analytical methods in order to understand the behaviour and evolution of proteins under different conditions, help scientists characterising proteins and different components of the formulation. They will also apprehend the manufacturing and scale up challenges, looking at compatibility problems, lyophilisation issues, and consider the different possibilities offered for drug delivery, keeping in mind the crucial need for improving comfort and safety to patient.

Attending this premier marcus evans conference will enable you to:

Improve the design of biological formulation with automated and highthroughput solutions

How can pharma companies progress with the new regulation?While some pharma companies focusing primary on fulfilling compliance standards, Merck is going one step further and is using the IDMP initiative to “go beyond compliance”.

Using this opportunity, pharma companies can highly benefit from IDMP and drive their internal digitalization; streamlining their processes landscape, data standards and IT architecture – one potential goal can be here the creation and establishment of a master data management system. By replacing manual paperwork with software, companies can use this flexibility to react quicker on updates of compliance requirements from authorities.

In addition, companies will be able to automatically gain information on their internal processes, data quality and managing their causes of risks. This new fact based capabilities can be used to improve patient services, enabled by a granular level of product traceability. Furthermore, business processes can be optimized as the improved data availability and quality can be used to drive initiatives to increase operational efficiency.

What are the challenges involved in the IDMP Project Change Management?

When it comes to the challenges of Change Management, it is important to understand that the IDMP project will impact a broad range of stakeholders along the entire value chain within the upcoming years. Starting with the focus on organizational data and growing over time with focus on product and substance information. In

addition, many details of IDMP are not yet finally decided and therefore not yet communicated and it will be defined by authorities in the

upcoming future. This impacts our ability to gain buy-in from team members and to give commitment to the stakeholders within the organization.

Considering these challenges, we have defined an engagement approach that is changing over time to fulfill the information needs of our stakeholders. The main idea of this approach is to include all project participants (beyond iteration 1) at a very early stage of the project. We are providing them with the progress of the IDMP Project on a frequent basis, even though their full participation will take place in several months in the future. In addition, stakeholders are informed on their expected date of engagement, helping them to prepare accordingly when higher level of attention is required.

Functions with deep project involvement are engaged directly via tailored roadshows. IDMP ambassadors are announced and trained to prepare each function on their upcoming roles and responsibilities to support the implementation of the project.

How would you advice companies to prepare for IDMP as a Long-Term Information Management Project?

Companies planning to implement the IDMP standard within their organization will need to keep up with the momentum over a long period in an evolving environment.

To manage this level of change, it is important to focus on areas that can be controlled by the company itself. In regards to IDMP, companies can focus on Master Data Management (MDM) as a significant milestone to drive the organization beyond compliance. Being able to manage its master data is an important capability that is required for IDMP, as well as for company’s operational requirements to provide additional business benefits. Changes within the organization range here from process changes up to the implementation of new IT systems and data cleansing.

To support stakeholders in the decision process within the project it is essential to build a culture of trust that deals with the evolving arena of IDMP. Associated there with, it is important to clearly communicate to stakeholders those decisions and definitions can change over time, as new information from authorities and updates of decisions are part of the project. The aimed business benefits of the project can be used as a beacon to give stakeholders orientation within their decision processes to define new processes, data standards, or adaption in their IT systems.

Furthermore, the early implementation of an “IDMP Office” is essential to manage the governance and maintenance of the IDMP Master Data. The office should be

designed as a network of IDMP Officers from several functions, who can support the organization as a single point of contact for IDMP related questions. Feedback initiated by authorities after submission can also be bundled and monitored by the IDMP Office, ensuring that these changes are sustainably implemented within the company.

Another point that should be mentioned deals with the preparation of the organization for new requirements. As insights in processes, medicinal products, organizational data, and substances will grow over time, the ability to interpret this insight will become more and more important. Training or hiring of Data Managers with analytical capabilities will therefore be essential to use the newly available insights provided by IDMP, or combine

them with other data available within the company.

Last but not least, companies should focus on a scalable IT landscape that is able to grow with the IDMP standard over time and can also be leveraged with additional initiatives required for authorities outside of Europe.

What would you like to achieve by attending the 4th Edition Impact of the Fundamental Review of the Trading Book Conference?

One of my major goals is to get in touch with industry representatives, in order to share my so far gained experience of the IDMP project at Merck. In addition, I am very curious how other professionals have engaged the IDMP project within their company and how they organized the project to keep up the momentum, staying flexible to react on upcoming changes from authorities.

Dr. Andrea Herrmann/Merck

About the speaker:

Andrea studied pharmacy in Heidelberg. After University, she started to work at Pharmalex in 2002 as a contractor for Merck KGaA and then in 2003 joined Merck KGaA holding different positions within Global Regulatory Affairs (GRA) (mainly in Regulatory International and some time in Regulatory Oncology).

While working at Merck, she first did her Master of Drug Regulatory Affairs at DGRA (“Deutsche Gesellschaft für Drug Regulatory Affairs”) in Bonn and afterwards she did her doctor of science at the University of Bonn in the field “Regulatory Affairs”.

Besides the science based trainings she attended over several years different coaching trainings and did a 2 years coaching education.

Within GRA, she held different positions, she was within Regulatory International responsible for the dossier updates for the new EU member states in 2004 and in 2007, responsible for all regulatory activities in Russia &CIS and South Eastern Europe, and then she took the lead to build up regulatory strategy for international countries for late stage and early stage oncology products. She has experience in registration of chemical and biological products worldwide. She also worked as a team lead and group head for coordinating and guidance of all regulatory activities for certain international regions. As a marketed product leader she was the strategic pillar for all regulatory activities for fertility products worldwide. Since April 2016 she is leading the IDMP project as Strategic Implementation Leader within Strategy and Business Operations.

Freitag, 27. Januar 2017

Boehringer Ingelheim is close to batting 1,000—as in the number of U.S. jobs eliminated during 2016.

The company on December 1 confirmed it had cut 244 additional U.S. jobs, five months after axing 725 U.S. positions. Nearly one-quarter of the total job cuts, 230, were positions based at Boehringer Ingelheim’s U.S. headquarters in Ridgefield, CT.

Among the latest layoffs, Boehringer eliminated 120 Ridgefield-based positions at its Small Molecule Discovery Research unit. The company is consolidating small-molecule research in Vienna and Biberach, Germany, while shutting units in Ridgefield and Milan, Italy.

Boehringer Ingelheim signaled its intent to get leaner in November 2015, saying it would spend E11 billion ($11.69 billion) on R&D through 2020. The figure includes €5 billion ($5.3 billion) to be assigned to preclinical R&D, and €1.5 billion ($1.6 billion) to be spent on external R&D partnerships—which already account for about half the programs in the early and middle stages of the company’s pipeline. The E11 billion averages E2.2 billion ($2.34 billion) a year, down from E3.004 billion ($3.19 billion) spent in 2015—reversing a year-over-year 13% R&D increase from E2.654 billion ($2.82 billion) in 2014.

“A key element of the new strategy is an increased focus on collaborations with external partners, while maintaining strong internal R&D capabilities,” Boehringer said back then.

The company insisted the latest job cuts will allow it to boost R&D in oncology, saying a new Ridgefield-based cancer immunology discovery research group will begin in 2017. “This new group will result in approximately 35 new positions in Connecticut,” Boehringer Ingelheim said in a statement.

Discovery & Development: Robots Have Feelings, Too

AstraZeneca is deploying a drug discovery robot that can safely share its workspace with scientists, so that it needn’t be sequestered behind glass walls. The robot, built by HighRes Biosolutions, is designed to be both collaborative and configurable.

Sensitive and responsive to the presence of scientists, the NiCoLA-B drug discovery robot safely occupies a shared workspace, swinging into action while sparing its human collaborators any roundhouse blows. Unlike most robots, NiCoLA-B can slow or even stop if it detects a change in its operating environment or if it encounters even the slightest resistance.

Built by HighRes Biosolutions and recently deployed by AstraZeneca, the motion- and load-sensing NiCoLA-B can test up to 300,000 compounds a day. (Operating at this rate, AstraZeneca’s robots will test 40 million chemicals each year.) NicCoLA-B uses sound waves, not pipettes, to move potential drugs, droplet by droplet, from storage tubes to individual wells on assay plates. Then, it adds droplets of cells or biochemical solutions. Finally, it oversees the interactions between the contents of the wells, checking for activity that might indicate a promising new drug.

As a drug discovery robot, NiCoLA-B illustrates a remarkable phenomenon: Drug discovery applications account for the largest share of the global lab automation market. This phenomenon was noted by Research and Markets, which attributed the size of drug discovery segment to the need for high-throughput screening and reduced time-to-market in biotech and pharma. Research and Markets estimates that the global lab automation market, currently worth $3.92 billion, will reach $5.48 billion by 2021.

Genomics & Proteomics: Charles River Goes “All In” on Genome Editing

CRL has developed significant global partnerships over the years with key groups for in vivo model creation services, which should allow for a smooth transition into the genome-editing arena.

“Utilizing the CRISPR-Cas9 platform, Charles River clients can work with a single provider for both the in vivo and in vitro phases of their research,” Dr. Morse noted. “Working with us, clients can generate custom cell lines for early, exploratory discovery research, as well as generate in vivo pharmacology models, produce those models, and then use our Discovery Services offering to place those models in in vivo studies.”

Synpromics agreed to collaborate with Sartorius Stedim Cellca to evaluate and test its customized synthetic promoters with Sartorius’ mammalian production cell platform.

“Synthetic promoters are DNA sequences that do not exist in nature,” explained David Venables, Ph.D., CEO, Synpromics, “and which are designed to regulate the activity of genes, controlling a gene’s ability to produce its own uniquely encoded protein.

“Our synthetic promoter technology has been developed to increase the yields of recombinant proteins produced by these stable cell lines which has a benefit in cost of goods reduction for biopharmaceuticals,” Venables told GEN.

Cellca has developed the Cellca CHO Expression Platform for the production of biologicals using CHO cells consisting of a proprietary cell line, growth medium, expression cassettes, and fed-batch process. The company said they have developed a panel of CHO-specific synthetic promoters, using their PromPT™ platform, designed and selected for optimized expression of recombinant proteins.

“The majority of recombinant proteins, including monoclonal antibodies, are produced using the CHO system,” Venables said. “We believe that the combination of Cellca’s CHO bioprocessing platform with Synpromics’ synthetic promoters will provide a much more efficient production system. We’re aiming for significantly higher levels of product being achieved which will increase capacity while reducing production costs.”

“We are delighted to be working with Synpromics on this exciting project,” added Christoph Zehe, Ph.D., head of technology development at Cellca. We believe it will offer significant benefit to our clients in being able to provide a superior production system for biological products.”

Separately, Sartorius Stedim Cellca announced that the company purchased property of more than 6,000 square meters at Ulm’s Science Park III at Eselsberg to build a laboratory and office complex. The new facility, which will approximately double the company’s space, is scheduled to be completed by the end of 2019. So far, Sartorius Stedim Cellca has been located in a rented building in Laupheim.

“Our new site’s proximity to universities and research institutes in Ulm’s Scientific Park offers an excellent environment to promote our growing business for which we are also seeking additional highly qualified staff,” said Hugo de Wit, managing director.

Good Start Genetics is making good on its pledge to democratize genetic testing. Two deals finalized late last year show the company’s commitment to making genetic testing more accessible.

First, in November the company inked a deal with Amazon, which will carry its VeriYou carrier screening test for cystic fibrosis and spinal muscular atrophy. It is anticipated that the convenience of Amazon and the price point ($149) will increase awareness and adoption of carrier screening.

“We think the main barriers to access and awareness are affordability and reach. Given our cost advantages in sequencing and breadth of reach, we are able to reach more of the 62 million women who should be offered screening for cystic fibrosis and spinal muscular atrophy,” Jeffrey R. Luber, president and CEO of Good Start Genetics, explained to GEN.

Then, in December, Roche Diagnostics agreed to offer Good Start Genetics’ GeneVu carrier screening test service in conjunction with its Harmony™ noninvasive prenatal test service to obstetricians and general practitioners providing care to pregnant women.

Luber summed up Good Start Genetics’ efforts by explaining “There is broad opportunity to couple genetic sequencing technologies and clinical expertise to provide health information to families. There are many genetic disorders for which early detection and intervention can have broad positive impact on individual outcomes while yielding societal savings. We believe testing for these disorders can be offered widely through low cost, high-quality testing like ours and unique business models that give families and physicians greater access to genetic information of importance to family health.”